Disposable Orthopaedic Surgery Kit and Components

ABSTRACT

A bone plate system for the internal fixation of a fractured bone of a patient has a bone plate with one or more threaded bone fastener apertures and one or more non-threaded bone fastener apertures. The system also has a plurality of bone fasteners, each with a shaft and a head. The heads are dimensioned and configured to threadedly engage the threaded bone fastener apertures to provide a fixed angle locking construct. The heads also are dimensioned and configured to directly engage the non-threaded bone fastener apertures to provide a polyaxial non-locking compressive construct.

RELATED APPLICATIONS

This application claims the benefit of provisional U.S. patentapplication No. 61/243,752 filed on Sep. 18, 2009.

BACKGROUND

This disclosure relates generally to surgical devices and procedures,and more particularly, to orthopaedic surgical devices and proceduresfor the internal fixation of fractured bones.

Bone plate systems for the internal fixation of fractured bones ofpatients are typically provided by manufacturers in non-sterile,reusable trays to the surgical care facilities. These trays may includea number of bone plates of various types, sizes and shapes for variouspatient anatomies and surgical indications. The trays also may include anumber of reusable instruments and a large number of bone platefasteners of numerous sizes and types, many more than what wouldnormally be required for any given patient and surgical indication.Prior to the surgical procedure, the surgical care facility personnelmust be sure that a complete tray of these components is assembled andsterilized, such as by steam autoclave. Often a manufacturer's salesrepresentative may be present at the facility to assist in assemblingthe tray of necessary components in preparation for the surgicalprocedure. After the procedure is completed, the tray of unusedcomponents may be sterilized and stored for a later surgical procedure.Any components missing from the tray generally are replenished and theentire tray is sterilized again prior to a surgical procedure foranother patient.

The overall cost of providing to the surgeon many more components insterile condition than would normally be required for a particularpatient with a specific surgical indication can be significant. Thisoverall cost may include costs related to the necessary inventory ofbone plate system components, repeated sterilization of the components,the need to make high quality, durable instruments for repeated use, theassistance of manufacturers' representatives, and other factors. Suchfactors may also impact the availability of such bone plate systems totrauma surgeons practicing in certain areas of the world.

BRIEF DESCRIPTION OF FIGURES

While this specification concludes with claims that particularly pointout and distinctly claim the invention, the following description andthe accompanying figures further illustrate some non-limiting examplesof the claimed invention. Unless otherwise indicated, like referencenumerals identify the same elements.

FIG. 1 is a top perspective view of a single-use, orthopaedic surgerykit (or more simply, a single-use kit), showing a first embodiment of acontainer sealed inside of an outer package;

FIG. 2 is a top perspective view of an alternative embodiment of acontainer, which includes a bottom tray and a top lid, shown with thelid closed;

FIG. 3 is a top perspective view of the container of FIG. 2, shown withthe lid opened;

FIG. 4 is a top perspective view of a single-use, distal volar radius(or DVR) kit;

FIG. 5 is a top perspective, detailed view of part of the DVR kit ofFIG. 4, showing a first fastener positioned in a fastener length gage;

FIG. 6 is a top perspective, detailed view of another part of the DVRkit of FIG. 4, showing a drill guide as it is removed from a driver andplaced into a reservoir of the container;

FIG. 7 is a top perspective, detailed view of another part of the DVRkit of FIG. 4, showing a retaining clip holding a DVR assembly in thecontainer;

FIG. 8 is a top perspective view of a single-use, DVR long kit;

FIG. 9 is a top perspective view of a single-use, fibula kit;

FIG. 10 is a top perspective view of a single-use, dorsal nail plate (orDNP) kit;

FIG. 11 is a top perspective view of a single-use, flexible fragmentfixation (or F3) kit;

FIG. 12 is a top perspective view of a single-use, proximal radius kit;

FIG. 13 is a top perspective view of a navicular kit;

FIG. 14 is a perspective view of a first drive instrument, which has afirst drive tip;

FIG. 15 is a perspective view of a depth gage for measuring the lengthof a hole extending through an aperture of a bone plate and a coaxiallydrilled hole in the bone, the depth gage shown in an extended position;and

FIG. 16 is a perspective view of the depth gage of FIG. 15, shown in aretracted position;

FIG. 17 is a perspective view of a pair of wire drills;

FIG. 18 is a perspective, detail view of the distal ends of the wiredrills shown in FIG. 17;

FIG. 19 is a perspective view of a first fastener, according to a secondembodiment;

FIG. 20 is a perspective view of a first fastener, according to a firstembodiment;

FIG. 21 is a perspective view of a second fastener;

FIG. 22 is a detail view of a first tapered, threaded head of the firstfastener shown in FIG. 20;

FIG. 23 is a detail view of a crest portion of a thread of the firsttapered, threaded head of FIG. 22;

FIG. 24 is a perspective, detail view of a double socket of the secondfastener shown in FIG. 21;

FIG. 25 is a perspective, detail view of the first drive tip shown inFIG. 14;

FIG. 26 is a perspective, detail view of a second drive tip;

FIG. 27 is a perspective view of a first drill guide;

FIG. 28 is a perspective view of a second drill guide;

FIG. 29 is a cross-sectional view of a non-locking aperture;

FIG. 30 is a cross-sectional view of a bone plate showing three possibletrajectories of the first fastener of FIG. 20 inserted into thenon-locking aperture of FIG. 29;

FIG. 31 is a cross-sectional view of a locking aperture;

FIG. 32 is a cross-sectional view of a bone plate with the firstfastener of FIG. 20 inserted at a fixed angle into the locking apertureof FIG. 31;

FIG. 33 is a top view of a unidirectionally ramped aperture;

FIG. 34 is a cross-sectional view of the unidirectionally rampedaperture of FIG. 33;

FIG. 35 is a cross-sectional view of the unidirectionally rampedaperture of FIG. 34 with the first fastener of FIG. 20 partiallyinserted therein;

FIG. 36 is a cross-sectional view of the unidirectionally rampedaperture of FIG. 35 with the first fastener of FIG. 20 fully insertedtherein;

FIG. 37 is a top view of a bidirectionally ramped non-locking aperture;

FIG. 38 is a cross-sectional view of the bidirectionally rampednon-locking aperture of FIG. 37;

FIG. 39 is a top view of a unidirectionally ramped slot positioned alonga longitudinal axis of a plate;

FIG. 40 is a cross-sectional view taken through the longitudinal axis ofthe plate of FIG. 39, showing a unidirectionally ramped slot;

FIG. 41 is a cross-sectional view taken through line 41-41 of FIG. 39,showing the unidirectionally ramped slot of FIG. 39;

FIG. 42 is a top view of the first fastener partially inserted into theunidirectionally ramped slot of the bone plate;

FIG. 43 is a top view of the first fastener fully inserted into theunidirectionally ramped slot;

FIG. 44 is a cross-sectional view, taken through the longitudinal axis,of the first fastener partially inserted into the unidirectionallyramped slot as shown in FIG. 42;

FIG. 45 is a cross-sectional view, taken through the longitudinal axis,of the first fastener fully inserted into the unidirectionally rampedslot as shown in FIG. 43;

FIG. 46 is a top view of a bidirectionally ramped slot in a bone plate;

FIG. 47 is a cross-sectional view, taken through the longitudinal axis,of the bidirectionally ramped slot of FIG. 46;

FIG. 48 is an end view of a first DVR assembly;

FIG. 49 is a top view of the first DVR assembly of FIG. 48;

FIG. 50 is a perspective view of the first DVR assembly of FIG. 48;

FIG. 51 is an end view of a second DVR assembly;

FIG. 52 is a top view of the second DVR assembly of FIG. 51;

FIG. 53 is a perspective view of the second DVR assembly of FIG. 51;

FIG. 54 is an end view of a third DVR assembly;

FIG. 55 is a top view of the third DVR assembly of FIG. 54; and

FIG. 56 is a perspective view of the third DVR assembly of FIG. 54.

SUMMARY

A disposable single indication orthopedic trauma surgical kit has nobone plates other than a single bone plate precountoured and sized tomatch an anatomic shape of a portion of a bone of a patient's extremity.The single bone plate has a plurality of fastener apertures. The kitalso has a plurality of fasteners, each comprising a head and a shaft.The heads are dimensioned to mate with the fastener apertures. The kitalso has a disposable torque driver adapted to engage the fastenerheads. The foregoing components are contained in a sterile sealedcontainer.

The portion of the bone may be any one of the right distal volar radius,the left distal volar radius, the right fibula, the left fibula, theright proximal radius, the left proximal radius, the right navicular,the left navicular, the right distal ulna, and the left distal ulna. Allof the fasteners in the surgical kit may have the same sized head, whileall of the fastener apertures of the single bone plate may bedimensioned to receive the same sized head. All of the fasteners in thesurgical kit may have only one of two different sized heads.Alternatively, all of the fasteners in the surgical kit may have eithera first sized head or a second sized head, while all of the fastenerapertures of the single bone plate may be dimensioned to receive eitherthe first sized head or the second sized head. The surgical kit mayinclude thirty-six or fewer fasteners, each of which may have only oneof nine or fewer different shaft lengths. The fasteners may be arrangedin the container in a plurality of groupings of four or fewer fasteners,each having the same shaft length. The container may include labels toindicate the shaft length of each of the plurality of groupings offasteners. The container may include a plurality of fastener lengthgages to aid the user in determining the length of each of the pluralityof fasteners. The surgical kit may also include a wire drill, a drillguide, and a depth gage, all contained in the sterile sealed container.In addition, the surgical kit may be resterilizable by a steam autoclaveonce the sterile sealed kit has been opened.

A disposable single indication orthopedic trauma surgical kit includes asingle bone plate adapted for a use on a bone of a patient's extremity.The bone plate has a plurality of fastener holes. The kit also has aplurality of fasteners, each comprising a head and a shaft. The headsare adapted to interface with the fastener holes. The kit also includesa disposable torque driver adapted to engage the fastener heads, one ormore wire drills, one or more drill guides, and a disposable depth gage.All of the foregoing components are contained in a sterile sealedcontainer.

A system of single indication orthopedic trauma surgical kits includes asterile sealed left DVR kit for treatment of fractures of the leftdistal volar radius. The left DVR kit includes a sterile sealedcontainer, a single bone plate that is anatomically shaped and sized tomatch the left distal volar radius, a plurality of fasteners, a fastenerdriver, a wire drill, a drill guide, and a depth gage. The system alsoincludes a sterile sealed right DVR kit for treatment of fractures ofthe right distal volar radius. The right DVR kit includes a sterilesealed container, a single bone plate that is anatomically shaped tomatch the right distal volar radius, a plurality of fasteners, afastener driver, a wire drill, a drill guide, and a depth gage. Thesystem also includes a sterile sealed fibula kit for treatment offractures of the fibula. The fibula kit includes a sterile sealedcontainer, a single bone plate that is anatomically shaped to match theright and left fibula, a plurality of fasteners, a fastener driver, awire drill, a drill guide, and a depth gage. The system also includes asterile sealed distal ulna kit for treatment of fractures of the distalulna. The distal ulna kit includes a sterile sealed container, a singlebone plate that is anatomically shaped to match the right and leftdistal ulna, a plurality of fasteners, a fastener driver, a wire drill,a drill guide, and a depth gage.

Each of the sterile sealed kits of the system may be steam autoclaveresterilizable after the kit has been opened. The containers of all thesterile sealed kits may have a common design that is configurable fordifferent surgical indications. Each kit may include displayed graphicsthat pertain to the surgical indication and use of the kit. Each kit mayhave one of a number of colors, each color corresponding to one of anumber of surgical indications.

A bone plate system for the internal fixation of a fractured bone of apatient has a bone plate with a bone-facing bottom surface, an opposingtop surface, and a thickness between the surfaces. The bone plate alsohas one or more threaded bone fastener apertures and one or morenon-threaded bone fastener apertures. The bone plate system further hasa plurality of bone fasteners, each fastener comprising a shaft and ahead. The heads are dimensioned and configured to threadedly engage thethreaded bone fastener apertures to provide a fixed angle lockingconstruct. The heads are also dimensioned and configured to directlyengage the non-threaded bone fastener apertures to provide a polyaxialnon-locking compressive construct.

At least one of the non-threaded bone fastener apertures may be aunidirectionally ramped aperture for dynamic compression of thefractured bone in one direction. The at least one unidirectionallyramped aperture may be an elongated slot. Also, the threaded andnon-threaded bone fastener apertures of the bone plate may have the samenominal size. At least some of the plurality of bone fasteners may bethreaded for engagement into bone and at least some of the plurality ofbone fasteners may have non-threaded, smooth shafts. The head of eachbone fastener may have a tapered external screw thread that has a flathelical crest defining a frustoconical shape. The tapered external screwthread may have either one of a double lead type of thread and a triplelead type of thread. The tapered external screw thread may have a pitchdistance between adjacent threads of about 0.500 to 0.600 millimeters.Furthermore, the flat helical crest may have a width in the range ofabout 0.120 to 0.160 millimeters and the ratio of the width of the flathelical crest to the pitch distance between threads may be about 0.200to 0.320. The bone plate may be sized and shaped for the internalfixation of a fractured bone of a human extremity. The bone plate mayalso include a shaft portion having a plurality of regions, each regionhaving one of the non-threaded bone fastener apertures and one of thethreaded bone fastener apertures paired together. A surgeon may attachthe bone plate to approximately the same part of the bone by selectingone of the threaded and non-threaded bone fastener apertures in any oneof the regions and inserting one of the bone fasteners into the selectedaperture.

A bone plate system for the internal fixation of a fractured bone of apatient has a bone plate with a bone facing bottom surface, an opposingtop surface, and a thickness between the surfaces. The bone plate alsohas a plurality of bone fastener apertures of a first size. Theplurality of bone fastener apertures have one or more apertures of afirst type having a tapered threaded surface and one or more aperturesof a second type having a tapered smooth surface. The bone plate systemalso has a plurality of bone fasteners, each comprising a shaft and ahead of a first size. The heads are dimensioned and configured tothreadedly engage the first type of bone fastener aperture to provide afixed angle locking construct. The heads are also dimensioned andconfigured to directly engage the second type of fastener aperture toprovide a polyaxial non-locking compressive construct.

The bone plate may have only bone fastener apertures of the first sizeand may also have one or more non-fastener apertures.

A bone plate system has a bone plate with a bone facing bottom surface,an opposing top surface, and a thickness between the surfaces. The boneplate further has a plurality of bone fastener apertures of a first sizeand a plurality of bone fastener apertures of a second size. The firstand second sized apertures each have one or more apertures of a firsttype having a tapered surface with internal threads and one or moreapertures of a second type having a tapered smooth surface. The boneplate system also has a plurality of first bone fasteners, eachcomprising a shaft and a head of a first size. The heads are dimensionedand configured to threadedly engage the first type of apertures of thefirst size to provide a fixed angle locking construct. The heads alsoare dimensioned and configured to directly engage the second typeapertures of the first size to provide a polyaxial non-lockingcompressive construct. The bone plate system also has a plurality ofsecond bone fasteners, each comprising a shaft and a head of a secondsize. The heads are dimensioned and configured to threadedly engage thefirst type of apertures of the second size to provide a fixed anglelocking construct. The heads are also dimensioned and configured todirectly engage the second type of apertures of the second size toprovide a polyaxial non-locking compressive construct.

The bone fastener apertures of the first and second sizes of the secondtype may have at least one unidirectionally ramped aperture fordynamically compressing the fractured bone in one direction. The bonefastener apertures of the first and second sizes of the second type mayinclude at least one bidirectionally ramped aperture for dynamicallycompressing the fracture bone in either one of two opposing directions.The head of the first bone fastener may have a first drive socket andthe head of the second bone fastener may include a second drive socket,and the first and second drive sockets may be dimensioned to receive adriver tip of a torque driver for insertion of the first and second bonefasteners into bone. Furthermore, the first drive socket may have afirst configuration. The second drive socket may have a stepped recesswith a distal recess having the first configuration and a coaxial,adjacent proximal recess with a second configuration. The secondconfiguration may be larger than the first configuration as viewed alongthe axis. Either one or both of the distal and proximal recesses cantransmit a torque from the torque driver to the head of the second bonefastener.

DETAILED DESCRIPTION

Throughout the following description, the term “user” may refer to thesurgeon or other users of the single-use kit, including surgicalassistants, technicians, and so on. Also, the term “single-use”, as usedherein, is interchangeable with the terms “disposable” or “disposable,single-indication”, meaning that the kit, including all the componentscontained therein, is intended for use for only one surgical patient.After completion of the surgical procedure, the components that are notimplanted into the patient may be discarded using conventional methods.However, for some embodiments, it is also possible that the single-usekit or a portion of it can be resterilized for use in a surgicalprocedure for another patient.

Each single-use kit is designed for transport from the manufacturer tothe surgical care facility, storage, and then finally, sterilepresentation to the surgeon for use during the surgical procedure. Usingthe appropriate single-use kit for a particular surgical procedure mayreduce the need for the surgical care facility to maintain a largeinventory of individual components that must be combined into a surgicaltray and sterilized prior to that procedure. Furthermore, using theappropriate single-use kit may reduce the need for special assistancefrom the representatives of the component manufacturers, and assures thesurgeon that the components are always new and in sterile condition. Inaddition, since the single-use kit may be designated to have a singleproduct code, expensing the cost of the kit to the patient and/or thepatient's health care provider may be simplified and result in reducedoverhead costs for the surgical procedure.

We envision that occasionally the surgeon may select a single-use kitcontaining components for a particular type of bone fracture procedure,and then determine during the surgical procedure that the single-use kitis not appropriate for that patient. In case a single-use kit iscontaminated during (or prior to) a surgical procedure for a patient andthen is not used for that patient, it is possible to steam autoclave thekit with the components contained therein, such that the kit may be usedin a surgical procedure for a different patient.

One advantage of these single-use kit embodiments is the commonality ofcomponents that is possible due to the reduction of the number of boneplate fastener types required, as compared to currently availablesystems for similar surgical procedures. By minimizing the variety ofrequired fastener types for attaching a plurality of different types ofbone plates, an economy is realized in the instrumentation required toperform the various surgical procedures. As a consequence, the size andcost of the single-use kit is minimized. We envision that this mayincrease availability of such kits to surgical care centers throughoutthe world, so that more trauma patients may be treated using the latestimplants, instruments and techniques. In addition, we envision that theoverall surgical procedure may be simplified, potentially resulting inreduced surgical procedure duration and improved clinical outcome forthe patient.

Referring now to the figures, FIG. 1 is a top perspective view of asingle-use kit 4, which includes a container 8 according to a firstembodiment, a plurality of components (not visible) contained therein,and an outer package 2. (Each of the plurality of components will belater described in detail for each of the single-use kit embodimentsdisclosed herein.) Outer package 2 physically protects container 8 andthe components contained therein, and may also serve to seal and tomaintain the sterility of container 8 and the components containedtherein until accessed prior to or during the surgical procedure.

Outer package 2 may be formed from materials and by methods that arewell known in the art for the sterile packaging of medical devices.Outer package 2 includes a pan 5 that is sized and shaped to holdcontainer 8. Pan 5 has a peripheral lip 3 and may be formed from aplastic material suitable for maintaining sterility. Outer package 2 mayinclude a removably attachable, sealing membrane 6 that is adhered toperipheral lip 3 of pan 5 prior to sterilization by gamma radiation orother sterilization methods known in the art. The user peels sealingmembrane 6 from pan 5 to access container 8. Sealing membrane 6 may beformed from a suitable, transparent plastic material so that a graphic20 displayed on container 8 is visible prior to opening outer package 2.Graphic 20 may provide information pertaining to, for example, themanufacturer, the distributor, the surgical indications, the productcode(s), the components contained therein, the overall physicalcharacteristics (i.e., size and weight), the relevant patents, warnings,directions for opening, and so on. Alternatively, sealing membrane 6 maybe formed from a suitable, solidly colored or translucent plasticmaterial, and may include a graphic that is similar or complementary tographic 20.

It should be understood that other embodiments of single-use kit 4 maynot include outer package 2 at all or that outer package 2 may provideonly non-sterile protection for container 8 and the components containedtherein. For example, container 8 and the components contained thereinmay be first removed from outer package 2 in a non-sterile condition andthen sterilized at the surgical care facility prior to the surgicalprocedure.

FIG. 2 is a top perspective view of a container 10 in a closedconfiguration according to a second embodiment. FIG. 3 is a topperspective view of container 10 in an open configuration. Container 10includes a bottom tray 22 and a top lid 12, each of which is formed,such as by injection molding, from any one of a number of polymers,including, for example, polysulfone, polyetherimide and polypropylene.Either one or both of tray 22 and lid 12 may be formed from atransparent polymer to allow viewing of the components contained thereinwithout opening container 10.

Lid 12 may be formed from a polymer that is colored to indicate thesurgical indication of the kit or to provide some other type ofinformation to the user. For example, a red color may indicate that thekit is to be used for the right side of the patient's anatomy, a limecolor may indicate that the kit is to be used for the left side, and awhite color may indicate that the kit is to be used for either side.

As shown in FIGS. 2 and 3, tray 22 has a rectangular shape defined byfour tray sides 24, although other shapes may be desirable depending onfunctional, economic, aesthetic or other reasons. Tray 22 includes atray bottom 26 that includes a plurality of openings 28 to facilitysteam access and drainage during sterilization. Lid 12 has a top portion16 and a peripheral lip 14 that is sized and shaped to fit closelyaround tray 22. Top portion 16 of lid 12 includes a plurality ofopenings 18 to facilitate steam sterilization and drainage of container10 and the components contained therein. Graphic 20 may be integrallymolded into top portion 16 of lid 12 and/or selectively highlighted witha suitable ink or paint, such as is well known in the art.

A pair of spaced apart, lid hinge elements 32 is integrally formed onlid 12 for attachment to a pair of spaced apart, tray hinge elements 33integrally formed on tray 22. Lid 12 may be removably attachable to tray22 to facilitate access to the components in tray 22 during the surgicalprocedure, while conserving available space on the surgical stand.

Similarly, a pair of spaced apart, lid latch elements 30, positioned onthe opposite side from lid hinge elements 32 of container 10, isintegrally formed on lid 12 for attachment to a pair of spaced apart,tray latch elements 31 formed on tray 22. As is well known in the art,many types of lid hinge elements 32, lid latch elements 30, tray hingeelements 33 and tray latch elements 31 are possible.

As shown in FIG. 4, tray 22 is compartmentalized by several, integrallyformed partitions 34 extending from the inside of tray bottom 26 and theinside of tray sides 24. Tray 22 also includes a shelf 36 that serves asan easily accessible, “screw caddy” for holding a plurality ofimplantable fasteners, including, for example, a plurality of firstfasteners 401 and a plurality of second fasteners 451 (as shown, forexample, in FIG. 8). Shelf 36 and partitions 34 are configured toorganize and retain the various combinations of all the requiredcomponents for at least each of the embodiments, as will be described,of the single-use kit embodiments shown herein.

Container 10, due to its versatility in design, may be used to containmany different combinations of components, depending on the surgicalindication, for at least each of the single-use kit embodimentsdescribed herein. FIGS. 4, 8, 9, 10, 11, 12 and 13 show a few of thepossible, single-use kit embodiments and may be referenced incombination. Each of these single-use kits is configured for a surgicalprocedure for the internal fixation of a particular bone of the arm,leg, hand or foot. FIG. 4 shows a distal volar radius kit 100 (or DVRkit 100) for a fracture of the distal radius of the forearm; FIG. 8shows a single use, DVR Long kit, also for a fracture of the distalradius of the forearm; FIG. 9 shows a single-use, fibula kit for afracture of the fibula of the lower leg; FIG. 10 shows a single-use,dorsal nail plate kit 210 (or DNP kit 210) for a fracture of the distalradius of the forearm; FIG. 11 shows a single-use, flexible fracturefixation kit 220 (or F3 kit 220) for a fracture of a small bone, such asof the hand or foot; FIG. 12 shows a single-use, proximal radius kit 240for a fracture of the proximal radius bone at the elbow; FIG. 13 shows asingle-use, navicular kit 230 for a fracture of the navicular bone ofthe foot.

As shown in FIG. 4 and also in the detailed view of FIG. 5, shelf 36includes a plurality of first receptacles 38 and a plurality of secondreceptacles 40. Each of first receptacles 38 is sized and shaped toloosely retain first fastener 401, which has a nominal size, forexample, of 2.7 mm, and each of second receptacles 40 is sized andshaped to loosely retain second fastener 451, which has a larger nominalsize, for example, of 3.5 mm. First receptacles 38 is integrally formedin lid 12, wherein each pair of first receptacles 38 is connected by abridge slot 39 to facilitate injection molding. Lid 12 includes aplurality of ribs 50 integrally formed into top portion 16, such thatwhen lid 12 is in a closed position as shown in FIG. 2, each of ribs 50abuts the exposed end of one of first fasteners 401 and second fasteners451, such that all of the fasteners are securely retained in container10.

First fastener receptacles 38 and second fastener receptacles 40 may bearranged such that plurality of first fasteners 401 and plurality ofsecond fasteners 451 may be arranged in tray 22 in a plurality ofgroupings of eight or fewer fasteners. Each grouping corresponds to aparticular one of a number of distinct fastener lengths. As shown in thepresent example, receptacles 38 and receptacles 40 are arranged ingroupings, such that each grouping may contain up to eight fasteners(four of first fasteners 401 and four of second fastener 451) of thesame shaft length. The number of receptacles within each groupings mayvary in other embodiments. For example, each grouping may include two,four or six receptacles for containing fasteners.

When lid 12 is opened, the user may easily grasp the exposed end of eachfastener and remove it from shelf 36. Alternately, the user may pickeach fastener from shelf 36 using the drive instrument to be described.Since each single-use kit may include only the number of first fasteners401 and second fasteners 451 required for the particular surgicalindication, with a few extra, a number of first receptacles 38 andsecond receptacles 40 may be empty.

Also as shown in FIGS. 4 and 5, shelf 36 includes a plurality offastener length gages 42, each of which is configured and labeled by asize label 44 for measuring incremental lengths of first fasteners 401and second fasteners 451. The incremental lengths may range, forexample, between 8 mm and 24 mm by 2 mm increments. Each of length gages42 has a seat 62, a channel 64 and a stop 66. As shown in FIG. 5, whenfirst fastener 401 of a particular, incremental length is mated into theappropriate one of gages 42, first fastener 401 fully fills thatparticular length gage without extending beyond seat 62. Using lengthgages 42, the surgeon may quickly confirm the length of a selectedfastener prior to implantation of the fastener into the patient, thusensuring that the fastener is of sufficient length to properly engagebone, but not so long as to protrude too far from the bone and into softtissue.

Still referring to FIG. 4, DVR kit 100 includes container 10 and aplurality of components that include a first DVR assembly 102, aplurality of first fasteners 401, and a first drive instrument 70. Thesurgeon may use first driver instrument 70 to transmit a torque anddrive each of first fasteners 401 into bone. The plurality of componentsof DVR kit 100 includes a depth gage 380 and at least one drill wire370. Each of the single-use kit embodiments disclosed herein contains avertically stacked, plurality of wire drills 370 that are retainedbetween one of tray sides 24 and one of partitions 34 of tray 22, suchthat the tips of wire drills 370 are shielded from the other componentsand the user's hands.

As shown in FIG. 4, DVR kit 100 includes twenty-four of first fasteners401, although the quantity may vary. An appropriate quantity of firstfasteners 401 of various lengths may be based on historical data forsimilar, distal volar radius fracture procedures, with a few morefasteners provide to allow for special circumstances (dropped or damagedfasteners, unusual fractures, etc.).

First DVR assembly 102 includes a first DVR bone plate 104 preassembledwith a plurality of first drill guides 330. The surgeon may use suchpreassembled drill guides to guide a wire drill when drilling holes intothe fractured bone, so that the drilled holes are properly aligned withthe apertures of the bone plate, and while also protecting the internalthreads of the apertures. Such preassembled drill guides may also beuseful for reshaping the bone plate using special bending instrumentsthat fit over the drill guides. After drilling each hole, the surgeonmay insert a drive end 80 of drive instrument 70 into drill guide 330and remove drill guide 130 from plate 104.

As shown in FIG. 6, each of a reservoir 46 and a stripping slot 47 isintegrally formed into container 10. The surgeon may use stripping slot47 to remove drill guide 330 from drive instrument 70, such that drillguide 330 falls into reservoir 46. In the embodiment shown, the user maycollect a plurality of drill guides in a easily visible, lineararrangement, such that the user can quickly account for the number ofdrill guides 330 that have been removed from plate 104. An instructivelabel 48 (the letters “FG” stand for Fast Guide™) aids the “first-time”user in understanding where to discard drill guides 330.

FIG. 7 is a top perspective, detailed view of part of DVR kit 100,showing a retaining clip 52 holding DVR assembly 100 between partitions34 of container 10. First slots 54 and second slots 56 are formed intocontainer 10, and clip 52 is configured, such that clip 52 may removablylock into one of first slots 54 and its opposing one of second slots 56.Clip 52 straddles over and retains DVR assembly 100, and is easilyremovable so that DVR assembly 100 may be lifted out of container 10.When container 10 is in the closed configuration, lid 12 abuts and holdsclip 52 in place. In this embodiment of container 10, three pairs ofslots 54 and 56 are provided to allow placement of clip 52 in threedifferent positions. This allows container 10 to have the versatility tocontain different types of bone plate assemblies.

FIG. 8 is a top perspective view of the single-use, DVR long 490 kit,which includes container 10 and a plurality of components, including aDVR long plate assembly 492, a plurality of first fasteners 401, aplurality of second fasteners 451, a plurality of wire drills 370, asecond driver 90 and a depth gage 380. DVR long plate assembly 492includes a plurality of first drill guides 330 preassembled to a DVRlong plate 494. DVR long plate 494 includes a plurality of apertures ofdifferent types to be described, such that the user may attach DVR longplate 494 to the fractured bone using at least a portion of each of theplurality of first fasteners 401 and the plurality of second fasteners451. (All bone plate apertures described herein should be understood tobe fastener apertures, as opposed to K-wire apertures, suturingapertures, etc.)

FIG. 9 is a top perspective view of the single-use, fibula kit 200,which includes container 10 and a plurality of components, including afibula plate assembly 202, plurality of first fasteners 401, pluralityof second fasteners 451, plurality of wire drills 370, second driver 90and depth gage 380. Fibula plate assembly 202 includes a plurality ofsecond drill guides 340 preassembled to a fibula plate 204. Fibula plate202 includes a plurality of apertures of different types to bedescribed, such that the user may attach fibula plate 204 to thefractured bone using at least a portion of each of the plurality offirst fasteners 401 and the plurality of second fasteners 451.

FIG. 10 is a top perspective view of the single-use, dorsal nail plate210 (or DNP) kit, which includes container 10 and a plurality ofcomponents, including a DNP plate assembly 212, a plurality of firstfasteners 401, a plurality of wire drills 370, first driver 70 and depthgage 380. Nail plate assembly 212 includes a DNP plate 494 removablyattached to a DNP handle 216. DNP plate 494 includes a plurality ofapertures to be described, such that the user may attach DNP plate 494to the fractured bone using at least a portion of each of the pluralityof first fasteners 401.

FIG. 11 is a top perspective view of the single-use, flexible fragmentfixation (or F3) kit 220, which includes container 10 and a plurality ofcomponents, including a F3 plate assembly 222, plurality of firstfasteners 401, plurality of wire drills 370, first driver 70 and depthgage 380. F3 plate assembly 222 includes a F3 plate 224 having aplurality of apertures to be described, such that the user may attach F3plate 224 to the fractured bone using at least a portion of each of theplurality of first fasteners 401. F3 kit 220 is particularly suitablefor the internal fixation of a fractured, distal ulna bone, andtherefore may also be referred to as a distal ulna kit.

FIG. 12 is a top perspective view of the single-use, proximal radius kit240, which includes container 10 and a plurality of components,including a proximal radius plate assembly 242, a plurality of firstfasteners 401, a plurality of wire drills 370, first driver 70 and depthgage 380. Proximal radius plate assembly 242 includes a proximal radiusplate 244 having a plurality of apertures to be described, such that theuser may attach proximal radius plate 244 to the fractured bone using atleast a portion of each of the plurality of first fasteners 401.

FIG. 13 is a top perspective view of the navicular kit 230, whichincludes container 10 and a plurality of components, including anavicular plate assembly 230, a plurality of second fasteners 451, aplurality of wire drills 370, second driver 90 and depth gage 380.Navicular plate assembly 230 includes a plurality of second drill guides340 preassembled with a navicular plate 236 having a plurality ofapertures to be described, such that the user may attach navicular plate244 to the fractured bone using at least a portion of each of theplurality of first fasteners 401. Navicular plate assembly 232 isremovably retained upon a board insert 234 that, in turn, is retainedwithin container 10 by a pair of T-rails 68 integrally formed intocontainer 10.

FIG. 14 is a perspective view of first drive instrument 70, which has ahandle 72 connected by an attachment 76 to a shaft 74 that defines alongitudinal axis 81. At the distal end of shaft 74 is a first drive end80 that includes a first drive tip 84. Handle 72 may be formed from arigid, high strength polymer. Shaft 74 may be formed from a stainlesssteel and has a proximal end (not visible in the figures) that isconfigured to be retainably insert-molded into handle 72 at attachment76. As will be further described in conjunction with FIG. 25, firstdrive tip 84 is configured for use with first fastener 401.

FIG. 15 is a perspective view of depth gage 380 for measuring the lengthof a hole extending through an aperture of a bone plate and a coaxiallydrilled hole in the bone, shown in an extended position. FIG. 16 is aperspective view of depth gage 380, shown in a retracted position. Depthgage 380 includes a body component 382 that frictionally fits over aslide component 384 having a distal and proximal end defining alongitudinal axis 390 therebetween. Body component 382 is adjustablymovable along slide component 384 along longitudinal axis 390. Each ofbody component 382 and slide component 384 may be injection molded froma rigid polymer. A feeler wire 386, which may be formed from stainlesssteel, is attached to body component 382 and extends distally alonglongitudinal axis 390 from the distal end of slide component 384. Feelerwire 386 includes a hook tip 387. A ring 388 is connected to theproximal end of slide component 384 and is sized and shaped for a thumbof the user. A spool portion 389 of body component 382 is sized andshaped for placement between, for example, the fore and middle fingersof the user. The slide component 384 includes indicia 385 thatcorresponds to the length of feeler wire 386 extending distally from thedistal end of slide component 384. The position of body component 382 isadjustable between a first stop 381 and a second stop 383 on slidecomponent 384. The frictional fit between slide component 384 and bodycomponent 382 is sufficient to maintain this position when the userreleases depth gage 380.

The user may measure the length of the aperture through the plate andbone, and thereby determine the length of the fastener needed, by firstfully extending feeler wire 386, then catching hook tip 387 on the edgeof the aperture on the far side of the bone. Then the user adjusts spoolportion 389 and ring 388 towards each other until the distal end ofslide component 384 abuts the top surface of the bone plate. The usermay read the indicia 385 that aligns with the proximal end of bodycomponent 382 and corresponds to the length of the aperture. Depth gage42 may also be used through a drill guide preassembled to the plate, inwhich case, the user may read the indicia 385 that aligns with theproximal end of second stop 383.

FIG. 17 is a perspective view of wire drill 370 and an alternate wiredrill 360. FIG. 18 is a perspective, detail view of the distal ends ofwire drill 370 and alternate wire drill 360. Each of wire drill 370 andalternate wire drill 360 may be formed from a stainless steel and arewell known in the art for drilling holes in bone, for the provisionalfixation of fractured bones, for provisional attachment of bone platesto bone, and for other uses. Wire drill 370 has a proximal end 372, adistal end 373, a longitudinal axis 371 extending therebetween, and afluted tip 376. Wire drill 360 has a proximal end 362, a distal end 364,a longitudinal axis 361 extending therebetween, and a spade tip 366.Each of the single-use kits disclosed herein may contain at least one ofalternate wire drill 360 and/or at least one of wire drill 370. Ingeneral, wire drill 370 may be used to prepare a pilot hole in bone forone of first fastener 401 and second fastener 451, so the diameter ofwire drill 370 is appropriately sized accordingly. One version of wiredrill 360 may be what is known in the art as a K-wire, which isprimarily used for provisional fixation, and may be provided, forexample, with a diameter of about 1.6 mm. The surgeon may insert theK-wire through any one of the aforementioned apertures of the boneplates described herein, but it is well-known in the art that theseplates may also include one or more smaller holes specifically forreceiving K-wires and/or for attaching sutures thereto.

FIGS. 19, 20 and 21 are perspective views of the same scale showing thefasteners that may be included in the single-use kits described herein.FIG. 20 is a perspective view of first fastener 401. FIG. 19 is aperspective view of an alternate embodiment of first fastener 401, alsoreferred to as a first fastener peg 431. FIG. 21 is a perspective viewof second fastener 451. Each of first fastener 401, first fastener peg431 and second fastener 451 may be formed from a metal such as atitanium alloy such as Ti-6A1-4V that is anodized for anti-galling andabrasion resistance. First fastener 401 and first fastener peg 431 mayhave a nominal size of 2.7 mm and second fastener 451 may have a nominalsize of 3.5 mm.

First fastener 401 has a head 404 and a shaft 408 that defines alongitudinal axis 420. Shaft 408 may be provided in a number ofincremental lengths, ranging from 8 mm to 24 mm by increments of 2 mm,for example. Head 404 includes a plurality of external threads 405 and adrive socket 412 that has an approximately square configuration. Shaft408 has a plurality of threads 409 and a tip 418 and is configured forself-tapping into a properly sized, drilled hole in the bone.

FIG. 22 is a detail view of head 404 of first fastener 401 shown in FIG.20. Threads 405 are conically tapered and define a taper angle 406 ofabout 12 degrees, centered on longitudinal axis 420. Threads 405 mayhave a double-lead type of thread as shown in FIG. 22. Head 404 isadapted for locking at a fixed angle into a tapered, threaded (locking)aperture of a bone plate, as is known in the art. But as will bedescribed herein, head 404 is also adapted for use in particularnon-threaded (non-locking) apertures. This is primarily due to theinclusion on threads 405 of crest portions 402 that have a crest width414 (FIG. 23).

Crest width 414, as shown in FIG. 22, is 0.141 millimeters, but may beapproximately in the range of 0.120 to 0.160 millimeters. A pitchdistance between adjacent crest portions 402, as shown in FIG. 22, is0.559, but may be approximately in the range of 0.500 to 0.600millimeters. Therefore, a ratio of crest width 414 to pitch distance, asshown in FIG. 22, is 0.252, but may be approximately in the range of0.200 to 0.320. Since crest portions 414 are relatively wide as comparedto tapered, threaded heads of some currently available bone fasteners,first fastener 401 may be driven with high compressive force into asmooth (non-threaded)aperture in various trajectories, such that threads405 are not “rolled over” or otherwise damaged during insertion. Withoutwidened, crest portion 414 on threads 405, it may be more likely thathead 404 would “pull through” the aperture of the plate under highcompressive load.

First fastener peg 431, shown in FIG. 19, includes a head 434 having adrive socket 442 and may be identical to head 404 of first fastener 401.First fastener peg 431 also includes a smooth shaft 438, a rounded tip448 and a longitudinal axis 450. Like shaft 408 of first fastener 401,shaft 438 may be provided in a number of incremental lengths, rangingfrom 8 mm to 24 mm by increments of 2 mm, for example. First fastenerpeg 431 is primarily used in locking (threaded) apertures.

As shown in FIG. 21, second fastener 451 includes a head 454, a shaft458 and a longitudinal axis 470. Head 454 includes tapered threads 455that may be a triple-lead type thread and include crest portions 456that provide the same advantages as described for threads 405 of firstfastener 401. As shown in FIG. 21, tapered threads 455 may have similardimensions for crest width and pitch distance, as compared to firstfastener 401 of FIG. 22. Shaft 458 has threads 459 and a tip 468 thatmay be conventionally designed for self-tapping into a drilled hole inthe bone. Second fastener 451 may also be provided, for example, in thesingle-use kits described herein with lengths in the range ofapproximately 8 mm to 24 mm in 2 mm increments.

FIG. 24 is a perspective, detail view of head 454 and a portion of shaft458 of second fastener 451 shown in FIG. 21. Head 454 includes adouble-socket 462 that is sized and shaped for optimal use with seconddrive instrument 90 (to be described next for FIG. 26), although it mayalso be used with first drive instrument 70. Double-socket 462 includesa distal recess 463 that is adjacent and coaxial to a proximal recess464 on longitudinal axis 470. Each of proximal recess 464 and distalrecess 463 may have an approximately square configuration with each pairof opposing sides on proximal recess 464 parallel to a correspondingpair of opposing sides on distal recess 463. The height of distal recess463 may be greater than the height of proximal recess 464. Proximalrecess 464 is wider than distal recess 463, thereby forming a ledge 465and fitting easily within the tapered shape of head 454 withoutweakening threads 455.

FIG. 25 is a perspective view of first drive end 80 of first driveinstrument 70. FIG. 26 is a perspective view of second drive end 92 ofsecond drive instrument 90. Each of first drive instrument 70 and seconddrive instrument 90, also referred to as torque drivers, may be use todrive each of first fastener 401 (including first fastener peg 431) andthe larger, second fastener 451. However, second drive instrument 90 maybe used to transmit more torque to second fastener 451 than what ispossible using first drive instrument 70.

As shown in FIG. 25, drive end 80 includes a conical portion 88 thattransitions distally, in the direction of axis 81, shaft 74 to a squaretaper portion 86, which in turn transitions to a square drive tip 84.When drive tip 84 is fully inserted into either one of drive socket 412of first fastener 401 or double-socket 462 of second fastener 451, aportion of square taper 86 wedges into the non-tapered sidewalls ofeither drive socket 412 or double-socket 462, respectively. This featurecauses either one of first fastener 401 or second fastener 451 to“stick” to the drive end of either one of first drive instrument 70 orsecond drive instrument 451, to facilitate removal of each fastener fromcontainer 10 and to position the fastener into one of the apertures ofthe bone plate and partially into the drilled hole in the bone prior totransmitting torque to drive the fastener into the bone.

As shown in FIG. 26, drive end 92 includes a first tapered squareportion 95 that transitions distally, in the direction of axis 91, shaft94 to a first square drive portion 96. A second tapered portion 97extends distally along axis 91 to a second square drive portion 98 thatis smaller than first square drive portion 96. When drive tip 92 isfully inserted into either one of drive socket 412 of first fastener 401or double-socket 462 of second fastener 451, a portion of second squaretaper portion 97 wedges into the non-tapered sidewalls of either ofdrive socket 412 or double-socket 462, respectively. When drive end 92is fully inserted into double-socket 462 of second fastener 451, atleast one of first tapered portion 95 or second tapered portion 97 stickinto double-socket 462. This also serves to aid the surgeon in thepick-up and placement of the fasteners. For obvious reasons, when alimited number of fasteners are readily available, it is highlydesirable to avoid dropping fasteners into the wound site of the patientor onto a non-sterile surface in the operating room.

FIG. 27 is a perspective view of a first drill guide 330 for use withone of the appropriately sized, wire drills 370, to drill a hole intobone for receiving first fastener 401. A plurality of first drill guides330 may be preassembled with bone plates as previously shown in FIGS. 4,8, 11 and 12. First drill guide 330 includes a body 336 having a distalend 332, a proximal end 334, and a bore 338 sized and shaped to guidethe appropriately sized wire drill 370 and defining a longitudinal axis331. Distal end 332 includes threads 333 for removable attachment to athreaded aperture of a bone plate. Proximal end 334 includes fourindentations 339 spaced evenly apart on the periphery of bore 338 forreceiving square drive tip 84 of first drive instrument 70 and seconddrive portion 98 of second drive instrument 90.

FIG. 28 is a perspective view of a second drill guide 340 for use withone of the appropriately sized, wire drills 370, to drill a hole intobone for receiving second fastener 451. A plurality of second drillguides 340 may be preassembled with bone plates as previously shown inFIGS. 9 and 13. Second drill guide 340 includes a body 346 having adistal end 342, a proximal end 344, and a bore 348 sized and shaped toguide the appropriately sized wire drill 370 and defining a longitudinalaxis 341. Distal end 342 includes threads 343 for removable attachmentto a threaded aperture of a bone plate. Proximal end 344 includes fourindentations 349 spaced evenly apart on the periphery of bore 348 forreceiving square drive tip 84 of first drive instrument 70 and seconddrive portion 98 of second drive instrument 90.

FIG. 29 is a cross-sectional view of a non-locking aperture 270 that maybe sized to receive first fastener 401. (The term “aperture”, as usedherein, is interchangeable with the term “hole”.) Similarly, althoughnot shown in detail views in the figures, non-locking aperture 270 mayalso be sized to receive second fastener 451. FIG. 30 is across-sectional view of a portion of a bone plate 271 (for no particularsurgical indication, but shown for description purposes), showing threepossible trajectories of first fastener 401 of FIG. 20 inserted intonon-locking aperture 270 of FIG. 29. Non-locking aperture 270 extendsbetween a top surface 286 and a bottom surface 284 of a plate 271 anddefines an axis 272. Non-locking aperture 270 has a conical upperportion 274 and tapers from top surface 286 towards the middle of plate271. A conical lower portion 278 is coaxial with conical upper portion274 and tapers from bottom surface 284 towards the middle of plate 271to form a waist 282 with conical upper portion 274. The position andorientation of waist 282 relative to top surface 286 may vary, but asshown in FIG. 29, is deep enough to receive head 404 of first fastener401, such that head 404 is not proud to top surface 286. As shown inFIG. 30, first fastener 401 may be inserted through plate 271 in anydesired trajectory within a range defined by a conical angle 422,wherein axes 401′, 401″ and 401′″ define three possible trajectories offirst fastener 401 within that range. This multidirectional abilityallows the surgeon to form a polyaxial non-locking compressiveconstruct.

FIG. 31 is a cross-sectional view of a locking aperture 250, which isvery similar to other locking apertures of bone plates that arewell-known in the art. FIG. 32 is a cross-sectional view of bone plate271 with first fastener 401 of FIG. 20 inserted at a fixed angle intolocking aperture 250. Similarly, although not shown in detailed views inthe figures, locking aperture 250 may be sized to receive secondfastener 451. Locking aperture 250 includes a tapered, threaded bore 254for receiving head 404 of first fastener 401. Bore 254 extends betweentop surface 286 and bottom surface 284 of plate 271 and defines an axis252. As shown in FIG. 32, when first fastener 401 is fully inserted intoplate 271, axis 420 of first fastener 401 is coaxial with axis 252 oflocking aperture 250. This arrangement allows the surgeon to form afixed-angle locking construct.

FIG. 33 is a top view of a unidirectionally ramped (or UR) aperture 290.FIG. 34 is a cross-sectional view of UR aperture 290. FIG. 35 is across-sectional view of UR aperture 290 with first fastener 401partially inserted therein. FIG. 36 is a cross-sectional view of URaperture 290 with first fastener 401 fully inserted therein. UR aperture290 may also be sized, although not shown in detail views in thefigures, to receive second fastener 451. UR aperture 290 is anon-locking type of aperture for compressively attaching the bone plateagainst the bone. The surgeon may also use UR aperture 290 to aid inreduction of the bone fragments, i.e., the compression of bone fragmentsalong the longitudinal axis of the bone plate, often referred to in theart as dynamic compression. As shown in FIGS. 35 and 36, properinsertion of first fastener 401 into UR aperture 290 causes plate 271 toshift in a direction depending on the orientation of UR aperture 290. Asshown in FIGS. 33 and 34, UR aperture 290 has an upper conical portion294 intersecting with a coaxially opposing, lower conical portion 298 toform a waist 282 about an axis 292, in an arrangement similar tonon-locking aperture 270 of FIG. 29. UR aperture 290 further includes acircular bore portion 306 defining an axis 307 that is parallel andoffset from axis 308. Circular bore portion 306 is sized to receiveshaft 408 of first fastener 401, but is too small to receive head 404.The surgeon may drill a hole into bone that is approximately coaxialwith axis 307 and then insert first fastener 401 as shown in FIGS. 35and 36, such that head 404 tends to seat into upper conical portion 294,and “ramp” in a translation direction along plate axis 272. Thetranslation distance possible is determined by an offset distance 308between axis 292 and 307.

FIG. 37 is a top view and FIG. 38 is a cross-sectional view of abidirectionally ramped (BR) aperture 501, which is similar to URaperture 290 of FIG. 34. BR aperture 501 may be sized to receive firstfastener 401 or second fastener 451. The surgeon may use BR aperture 501to compressively attach bone plate 271 against the bone, and also todynamically compress the bone fragments along the longitudinal axis ofplate 271 in either of opposing directions. This bidirectional featureallows the surgeon to reduce fragments on either side of BR aperture501. BR aperture 501 includes an upper conical portion 504 defining anaxis 502, a coaxial, lower conical portion 508, a waist 512, a firstcircular bore portion 516 defining an axis 517, and an opposing secondcircular bore portion 518 defining an axis 519. The surgeon may use BRaperture 501 with first fastener 401 to translate plate 271 an offsetdistance 521 in a first direction along axis 272 of plate 271, or anoffset distance 522 in a second, opposing direction along axis 272.

FIG. 39 is a top view of a unidirectionally ramped (UR) slot 310positioned along axis 272 of plate 271. FIG. 40 is a cross-sectionalview of UR slot 310, taken through axis 272; FIG. 41 is across-sectional view of UR slot 310, taken through line 41-41 of FIG.39; FIG. 42 is a top view of first fastener 401 partially inserted intoUR slot 310; FIG. 43 is a top view of first fastener 401 fully insertedinto the UR slot 310; FIG. 44 is a cross-sectional view, taken throughaxis 272, of first fastener 401 partially inserted into UR slot 310;FIG. 45 is a cross-sectional view, taken through axis 272, of firstfastener 401 fully inserted into the UR slot 310. UR slot 310 is moreelongated than UR aperture 290, and also may be used to dynamicallycompress bone fragments as first fastener 401 is inserted into bone. Theuse of slotted apertures similar to UR slot 310 in bone plates iswell-known in the art for reducing bone fragments as the surgeonattaches the plate to the bone. UR slot 310 has an elongated, taperedportion 314 that defines a slot axis 315 and tapers from top surface 286to bottom surface 284 of plate 271. A circular bore portion 312 isformed into one end of tapered portion 314 and is sized to receive shaft408 of first fastener 401, but not head 404. As the surgeon insertsfirst fastener 401 into bone as shown in FIGS. 44 and 45, head 404 tendsto seat into tapered portion 310 and move plate 271 in a direction alongaxis 272 a distance 317 (FIG. 45).

FIGS. 46 and 47 shown a bidirectionally ramped (BR) slot 320 that issimilar to UR slot 310, except the surgeon may use BR slot 320 todynamically compress bone fragments in either of opposing directionsalong axis 292 of plate 271. BR slot 320 includes an elongated, taperedportion 325 that tapers from top surface 286 to bottom surface 284 ofplate 271. A first circular bore portion 322 and a second circular boreportion 325 are formed into opposing ends of tapered portion 325.

Each of UR slot 310 and BR slot 320 may be sized to receive either firstfastener 401 or second fastener 451.

FIG. 48 is an end view, FIG. 49 is a top view, and FIG. 50 is aperspective view of a first DVR assembly 102 that was earlier describedfor FIG. 4. First DVR assembly 102 includes a first DVR plate 114 thathas a head 106, a neck 108 and a shaft 110 that extends along alongitudinal axis 101.

Head 106 includes a plurality of locking apertures 250, each of which isassembled with a first drill guide 330. Each of locking apertures 250 ofhead 106 defines a desired, fixed trajectory, such that insertion offirst fastener 401 into each locking aperture 250 of head 106 providessubchondral support of the articulation surface of the wrist joint ofthe distal radius.

Shaft 110 includes a plurality of locking apertures 250, a plurality ofnon-locking apertures 270, and one UR slot 310, wherein the respectiveaxis of each aperture is generally directed inwardly towards the centerof the underlying bone. Each of locking apertures 250 is assembled withone of first drill guides 330. Each of locking apertures 250,non-locking apertures 270, and UR slot 310 is sized for receiving firstfastener 401. Each locking aperture 250 of shaft 110 is paired closelytogether with one of the non-locking apertures 270 to form four,spaced-apart, groupings or clusters, including a first grouping 120, asecond grouping 130, a third grouping 140 and a fourth grouping 146, andcorresponding to a first region 121, a second region 131, a third region141, and a fourth region 147 on shaft 110. First grouping 120 opposessecond grouping 130 about longitudinal axis 111 of plate 104, such thataperture axes 123 and 125 of first grouping 120 cross-over aperture axes133 and 135 of second grouping 130. Similarly, third grouping 140opposes fourth grouping 146.

During the surgical procedure, the surgeon may insert one of firstfasteners 401 into each of regions 121, 131, 141, and 147. The surgeonmay choose whether to select one of locking apertures 250 or one ofnon-locking apertures 270 for each region. In general, surgeons maychoose to use locking apertures 250 if the underlying bone is not incondition to provide optimal engagement with the threads of shaft 110 offirst fastener 401.

It should be appreciated that first DVR assembly 102 may be attached tothe distal radius of a patient using only one type of bone fastener,i.e., a plurality of first fasteners 401 of varying lengths. In manycurrent bone plate systems for fixation of the distal radius, a numberof different types of fasteners are required. By using only one type, itis possible to reduce the number of instruments required in DVR kit 100,thereby reducing the size of container 10 (FIG. 4) and potentiallylowering the overall cost of DVR kit 100. Using only one type offastener also may help surgeons, especially those who are not greatlyexperienced doing the procedure, to perform the surgical procedure morequickly and without using the fasteners inappropriately.

FIG. 51 is an end view, FIG. 52 is a top view, and FIG. 53 is aperspective view of a second DVR assembly 152, which includes a secondDVR plate 154 assembled with a plurality of first drill guides 330, anda plurality of second drill guides 340. Second DVR plate has a head 156,a neck 158 and a shaft 160 that extends along a longitudinal axis 161.

Head 156 includes a plurality of locking apertures 250, each of which isassembled with one of first drill guides 330 and is sized for receivingone of first fasteners 401. Each of locking apertures 250 of head 156defines a desired, fixed trajectory, such that insertion of firstfastener 401 into each locking aperture 250 of head 156 providessubchondral support of the articulation surface of the wrist joint ofthe distal radius.

Shaft 154 includes two of locking apertures 250, each of which isassembled with one of second drill guides 340 and is sized to receiveone of second fasteners 451. Each of locking apertures 250 in shaft 154is paired closely together with one of UR apertures 290, each of whichis sized to receive one of second fasteners 451, to form a firstgrouping 170 that is spaced apart from a second grouping 180 along axis161. First grouping 170 corresponds to a first region 171 and secondgrouping 180 corresponds to a second region 181 of plate 154. As forfirst DVR assembly 102, the axes 173, 175, 183 and 185 of the aperturesof shaft 160 of second DVR assembly 152 are generally directed towardsthe center of the bone. Shaft 154 also includes BR slot 320 positionedapproximately midway along axis 161.

Second DVR assembly 152 requires two types of fasteners, i.e., firstfasteners 401 and second fasteners 451 of varying lengths. However, weenvision that using two of second fasteners 451 in shaft 160 precludesthe need to use four of first fasteners 401 in shaft 110 of first DVRassembly 102. This facilitates a quicker surgical procedure andeliminates the cost of the additional two fasteners.

Another feature of second DVR assembly 152 is the enhanced ability todraw the fractured bone fragments together axially as the fasteners areinserted. That is because, the dynamic compression that is achievableusing UR apertures 290, if done in proper sequence, may be additive tothe dynamic compression that is achievable using UR slot 310.

FIG. 54 is an end view, FIG. 55 is a top view, and FIG. 56 is aperspective view of a third DVR assembly 552, which includes a third DVRplate 554 assembled with a plurality of first drill guides 330, and aplurality of second drill guides 340. Third DVR plate 554 has a head556, a neck 558 and a shaft 560 that extends along a longitudinal axis561.

Head 556 includes a plurality of locking apertures 250, each of which isassembled with one of first drill guides 330 and is sized for receivingone of first fasteners 401. Each of locking apertures 250 of head 556defines a desired, fixed trajectory, such that insertion of firstfastener 401 into each locking aperture 250 of head 556 providessubchondral support of the articulation surface of the wrist joint ofthe distal radius.

Shaft 554 includes two of locking apertures 250, each of which isassembled with one of second drill guides 340 and is sized to receiveone of second fasteners 451. Each of locking apertures 250 in shaft 554is paired closely together with one of BR apertures 320, each of whichis sized to receive one of second fasteners 451, to form a firstgrouping 570 that is spaced apart from a second grouping 580 along axis561. First grouping 570 corresponds to a first region 571 and secondgrouping 180 corresponds to a second region 581 of plate 554. As for thepreviously described DVR assemblies 102 and 152, the axes of theapertures of shaft 560 of third DVR assembly 552 are generally directedtowards the center of the bone. Shaft 554 also includes BR slot 320positioned approximately midway along axis 561.

Third DVR assembly 552 requires two types of fasteners, i.e., firstfasteners 401 and second fasteners 451 of varying lengths. However, asfor second DVR assembly 152, we envision that using two of secondfasteners 551 in shaft 560 precludes the need to use four of firstfasteners 401 in shaft 110 of first DVR assembly 102. This facilitates aquicker surgical procedure and eliminates the cost of the additional twofasteners.

Again as with second DVR assembly 152, third DVR assembly 552 has theenhanced ability to draw the fractured bone fragments together axiallyas the fasteners are inserted since the dynamic compression that isachievable using BR apertures 501, if done in proper sequence, may beadditive to the dynamic compression that is achievable using BR slot320. However, third DVR assembly 552 has the additional ability toprovide dynamic compression in either direction along axis 561 of plate554.

We have shown and described various embodiments and examples. However, aperson having ordinary skill in the art may modify the methods anddevices described herein without departing from the overall concept. Forinstance, the specific materials, dimensions and the scale of drawingsshould be understood to be non-limiting examples. Accordingly, we do notintend the scope of the following claims to be understood as limited tothe details of structure, materials or acts shown and described in thespecification and drawings.

1. A bone plate system for the internal fixation of a fractured bone ofa patient, the system comprising: a bone plate comprising a bone-facingbottom surface, an opposing top surface, and a thickness between thesurfaces, the bone plate further comprising one or more threaded bonefastener apertures and one or more non-threaded bone fastener apertures;and a plurality of bone fasteners, each fastener comprising a shaft anda head, the heads being dimensioned and configured to threadedly engagethe threaded bone fastener apertures to provide a fixed angle lockingconstruct, the heads also being dimensioned and configured to directlyengage the non-threaded bone fastener apertures to provide a polyaxialnon-locking compressive construct.
 2. The bone plate system of claim 1,wherein the one or more non-threaded bone fastener apertures include atleast one unidirectionally ramped aperture for dynamic compression ofthe fractured bone in one direction.
 3. The bone plate system of claim2, wherein the at least one unidirectionally ramped aperture is anelongated slot.
 4. The bone plate system of claim 1, wherein the boneplate is sized and shaped for the internal fixation of a fractured boneof a human extremity.
 5. The bone plate system of claim 1, wherein atleast some of the plurality of bone fasteners are threaded forengagement into bone.
 6. The bone plate system of claim 1, wherein atleast some of the plurality of bone fasteners comprise non-threaded,smooth shafts.
 7. The bone plate system of claim 1, wherein the head ofeach bone fastener comprises a tapered external screw thread that has aflat helical crest defining a frustoconical shape.
 8. The bone platesystem of claim 7, wherein the tapered external screw thread has eitherone of a double lead type of thread and a triple lead type of thread,and the tapered external screw thread has a pitch distance betweenadjacent threads of about 0.500 to 0.600 millimeters.
 9. The bone platesystem of claim 8, wherein the flat helical crest has a width in therange of about 0.120 to 0.160 millimeters.
 10. The bone plate system ofclaim 8, wherein the ratio of the width of the flat helical crest to thepitch distance between threads is about 0.200 to 0.320.
 11. The boneplate system of claim 1, wherein the threaded and non-threaded bonefastener apertures of the bone plate have the same nominal size.
 12. Thebone plate system of claim 1, wherein the bone plate further comprises ashaft portion having a plurality of regions, each region having one ofthe non-threaded bone fastener apertures and one of the threaded bonefastener apertures paired together, wherein a surgeon may attach thebone plate to approximately the same part of the bone by selecting oneof the threaded and non-threaded bone fastener apertures in any one ofthe regions and inserting one of the bone fasteners therein.
 13. A boneplate system for the internal fixation of a fractured bone of a patient,the system comprising: a bone plate comprising a bone facing bottomsurface, an opposing top surface, and a thickness between the surfaces,the bone plate further comprising a plurality of bone fastener aperturesof a first size, said plurality of bone fastener apertures comprisingone or more apertures of a first type having a tapered threaded surfaceand one or more apertures of a second type having a tapered smoothsurface; a plurality of bone fasteners, each comprising a shaft and ahead of a first size, the heads being dimensioned and configured tothreadedly engage the first type of bone fastener aperture to provide afixed angle locking construct, the heads also being dimensioned andconfigured to directly engage the second type of fastener aperture toprovide a polyaxial non-locking compressive construct.
 14. The boneplate system of claim 13, wherein the bone plate consists only of bonefastener apertures of the first size.
 15. The bone plate system of claim14, wherein the bone plate further comprises one or more non-fastenerapertures.
 16. A bone plate system for the internal fixation of afractured bone of a patient, the system comprising: a bone platecomprising a bone facing bottom surface, an opposing top surface, and athickness between the surfaces, the bone plate further comprising aplurality of bone fastener apertures of a first size and a plurality ofbone fastener apertures of a second size, the first and second sizedapertures each comprising one or more apertures of a first type having atapered surface with internal threads and one or more apertures of asecond type having a tapered smooth surface; a plurality of first bonefasteners, each comprising a shaft and a head of a first size, the headsbeing dimensioned and configured to threadedly engage the first type ofapertures of the first size to provide a fixed angle locking construct,the heads also being dimensioned and configured to directly engage thesecond type apertures of the first size to provide a polyaxialnon-locking compressive construct; and a plurality of second bonefasteners, each comprising a shaft and a head of a second size, theheads being dimensioned and configured to threadedly engage the firsttype of apertures of the second size to provide a fixed angle lockingconstruct, the heads also being dimensioned and configured to directlyengage the second type of apertures of the second size to provide apolyaxial non-locking compressive construct.
 17. The bone plate systemof claim 16, wherein the bone fastener apertures of the first and secondsizes of the second type includes at least one unidirectionally rampedaperture for dynamically compressing the fractured bone in onedirection.
 18. The bone plate system of claim 16, wherein the bonefastener apertures of the first and second sizes of the second typeincludes at least one bidirectionally ramped aperture for dynamicallycompressing the fracture bone in either one of two opposing directions.19. The bone plate system of claim 16, wherein the head of the firstbone fastener includes a first drive socket and the head of the secondbone fastener includes a second drive socket, and the first and seconddrive sockets are dimensioned to receive a driver tip of a torque driverfor insertion of the first and second bone fasteners into bone.
 20. Thebone plate system of claim 19, wherein the first drive socket has afirst configuration and the second drive socket has a stepped recesscomprising a distal recess having the first configuration and a coaxial,adjacent proximal recess that has a second configuration that is largerthan the first configuration as viewed along the axis, and either one orboth of the distal and proximal recesses can transmit a torque from thetorque driver to the head of the second bone fastener.